Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not

Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.

GUEST COLUMNISTS

CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?
Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.
April 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.
Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
Gaining An Edge In GLP-1 Production
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.
How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls
The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.
Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

PHARMA OUTSOURCING WHITE PAPERS

The Relevance Of Polymorph Screening In The Pharmaceutical Industry
Polymorph screening identifies different solid forms of active pharmaceutical ingredients, optimizing drug stability, solubility, and manufacturability. This process ensures quality, regulatory compliance, and intellectual property protection in pharmaceutical development.

Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing
Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.
A Simple And Powerful Solution For Accelerating Dissolution
Many poorly soluble drugs fail not because of low solubility, but because they dissolve too slowly. Learn how focusing on dissolution rate can unlock absorption gains using simple strategies.
Accelerating ADC Clinical Development Timelines
For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.
AAV-Based Gene Editing For Huntington's Disease
LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.